FDA Regulations for the Dental Laboratory

21 CFR Part 820
21 CFR Part 820 is the legal code concerning the FDA's powers over dental devices. The code went into effect in 1997. The code is known as the Quality System Regulation code and it allows the FDA to regulate imported dental items. Under the code, dental laboratories must use properly labeled and designed dental products for their intended dental procedure. The FDA is known to randomly check all dental offices to make sure the offices are under the 21 CFR Part 820.
Mandatory CertificationThe FDA mandates that every dental laboratory in the United States is certified. A dental laboratory can be certified by the National Board for Certification in Dental Laboratory Technology. For a dental laboratory to be certified, the office must demonstrate to the National Board that laboratory fully employs Certified Dental Technicians. The laboratory must also have proper, technological fixtures in the office, such as proper lightning for dental procedures and a working ventilation system. The laboratory must demonstrate it updates its services and technology with the newest progressions in dental technology. Once an office has demonstrated these aspects to the National Board, the laboratory can receive a Certified Dental Laboratory marker. The FDA requires that dental laboratories must obtain certification. Additionally, dental laboratories have the option of being certified by the Dental Appliance Manufacturers Audit Scheme.
State By State RegulationsThe FDA allows states, on a case by case basis, to institute their own regulations on dental laboratories. The states can also negotiate with the FDA for more flexible standards. The states of Texas, South Carolina, Kentucky and Florida have specific standards and regulations. For example, each state has their own certification fee that is different from the general free the other 46 states pay. Another example is that the states have to register their laboratories with their own state dental regulatory organization, except for South Carolina.
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